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Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant)
INTRODUCTION: Healthy dietary patterns and physical activity (PA) represent important lifestyle behaviors with considerable potential to influence on age-related metabolic health. Yet, data on the combined effects of these lifestyle behaviors on metabolic health including low-grade systemic inflamma...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220060/ https://www.ncbi.nlm.nih.gov/pubmed/32311926 http://dx.doi.org/10.1097/MD.0000000000019584 |
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author | Bergens, Oscar Veen, Jort Montiel-Rojas, Diego Edholm, Peter Kadi, Fawzi Nilsson, Andreas |
author_facet | Bergens, Oscar Veen, Jort Montiel-Rojas, Diego Edholm, Peter Kadi, Fawzi Nilsson, Andreas |
author_sort | Bergens, Oscar |
collection | PubMed |
description | INTRODUCTION: Healthy dietary patterns and physical activity (PA) represent important lifestyle behaviors with considerable potential to influence on age-related metabolic health. Yet, data on the combined effects of these lifestyle behaviors on metabolic health including low-grade systemic inflammation in aging populations remain scarce. Therefore, this protocol describes a randomized controlled trial aiming to examine the impacts of healthy dietary patterns alone or combined with PA on metabolic health in middle-aged and older men and women. MATERIAL AND METHODS: The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON). The trial is open label, randomized with allocation concealment, parallel groups with passive controls. Participants without overt disease aged between 55 and 70 years, with BMI below 35, a current intake of a maximum of 1 serving of fruit and vegetable per day, and noncompliance to PA guidelines are eligible for inclusion. Participants in HD are instructed to increase fruit and vegetable intake to 5 servings per day (equivalent to 500 g). Participants in HD-PA receive the same dietary intervention as the HD and are additionally instructed to engage in moderate-to-vigorous physical activities for at least 150 minutes per week. The primary study outcomes are changes in metabolic and inflammatory health biomarkers. Secondary outcomes are changes in body composition and perceived health. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethical review board in Uppsala, Sweden. The results will be published in peer-reviewed journals and disseminated in national and international conferences. TRIAL REGISTRATION NUMBER: NCT04062682 Pre-results |
format | Online Article Text |
id | pubmed-7220060 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-72200602020-06-15 Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) Bergens, Oscar Veen, Jort Montiel-Rojas, Diego Edholm, Peter Kadi, Fawzi Nilsson, Andreas Medicine (Baltimore) 5500 INTRODUCTION: Healthy dietary patterns and physical activity (PA) represent important lifestyle behaviors with considerable potential to influence on age-related metabolic health. Yet, data on the combined effects of these lifestyle behaviors on metabolic health including low-grade systemic inflammation in aging populations remain scarce. Therefore, this protocol describes a randomized controlled trial aiming to examine the impacts of healthy dietary patterns alone or combined with PA on metabolic health in middle-aged and older men and women. MATERIAL AND METHODS: The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON). The trial is open label, randomized with allocation concealment, parallel groups with passive controls. Participants without overt disease aged between 55 and 70 years, with BMI below 35, a current intake of a maximum of 1 serving of fruit and vegetable per day, and noncompliance to PA guidelines are eligible for inclusion. Participants in HD are instructed to increase fruit and vegetable intake to 5 servings per day (equivalent to 500 g). Participants in HD-PA receive the same dietary intervention as the HD and are additionally instructed to engage in moderate-to-vigorous physical activities for at least 150 minutes per week. The primary study outcomes are changes in metabolic and inflammatory health biomarkers. Secondary outcomes are changes in body composition and perceived health. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethical review board in Uppsala, Sweden. The results will be published in peer-reviewed journals and disseminated in national and international conferences. TRIAL REGISTRATION NUMBER: NCT04062682 Pre-results Wolters Kluwer Health 2020-04-17 /pmc/articles/PMC7220060/ /pubmed/32311926 http://dx.doi.org/10.1097/MD.0000000000019584 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | 5500 Bergens, Oscar Veen, Jort Montiel-Rojas, Diego Edholm, Peter Kadi, Fawzi Nilsson, Andreas Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) |
title | Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) |
title_full | Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) |
title_fullStr | Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) |
title_full_unstemmed | Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) |
title_short | Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant) |
title_sort | impact of healthy diet and physical activity on metabolic health in men and women: study protocol clinical trial (spirit compliant) |
topic | 5500 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220060/ https://www.ncbi.nlm.nih.gov/pubmed/32311926 http://dx.doi.org/10.1097/MD.0000000000019584 |
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